Researchers Conduct Phase I/II Study of Biweekly Paclitaxel and Radiation in Androgen-Ablated Locally Advanced Prostate Cancer

Newswise — A phase I/II trial of men who were at high risk for prostate cancer was conducted at the NYU Cancer Institute. The purpose of the trial was to determine the maximum tolerated dose (MTD) of concurrent paclitaxel and radiation therapy (RT) in patients with locally advanced prostate cancer.

This study is published in the June 18, 2008, issue of the Journal of Clinical Oncology.

This study tested concurrent chemotherapy and radiation with hormonal ablation. The key in this study was adding the chemotherapy. Normally patients undergo radiation and hormonal ablation solely. Nicholas Sanfilippo, M.D. assistant professor of radiation oncology, says, "Our study shows that concurrent paclitaxel and radiation therapy is well tolerated and early clinical results are encouraging in a patient population with high risk tumor features."

The trial was designed to enroll 22 men who had clinical stage T2-4 tumors with Gleason scores greater than 7 and/or prostate specific antigen (PSA) levels greater than 10, or they had pathologic lymph node involvement. The median age was 59 years and the median PSA level was 22.4.

The early outcome is encouraging and further research is needed.

According to the American Society of Clinical Oncology, prostate cancer is the most common malignancy in men in the United States and is the second leading cause of cancer-related mortality.